JP2010534059A - Portable detection system and method - Google Patents

Abstract

  A method and apparatus for providing assay information to a portable detection unit via a remote server in communication with the portable detection unit or a consumable having stored information for use with the portable detection unit. Global positioning system (GPS) information is provided to a portable detection unit having a GPS receiver so that the portable detection unit can determine its current location, including altitude. Based on the determined location, assays and parameters, such as PCR melting temperature, can be selected. The analysis to be performed by the portable detection unit can be selected based on the results of the pre-assay.

Description

  The present invention relates generally to the field of portable detection systems. More particularly, the present invention provides communication capabilities for a portable detection device so that the portable detection device can receive data from the server and send data to the server, and portable It relates to a method and system for allowing a detection device to determine the position and height to be used in an assay analysis computation. The ability to send and receive data can be used, for example, to determine what type of analysis is to be performed, or parameters that are to be used to perform the analysis. The result can be sent to the server.

  This application claims priority to US Provisional Patent Application No. 60 / 929,577, filed July 3, 2007, which is hereby incorporated by reference in its entirety. It is.

  As the threat of terrorism becomes more pronounced, portable detection units are becoming very useful in today's society. More specifically, bioterrorism and biological wars pose both physical and psychological threats to military and civilian units and the general public.

  The difficulty and time needed to identify potentially dangerous biological or chemical agents amplifies the risks and fears associated with biological warfare. For example, potential threats include unknown liquids left in subway stations and unknown gases emanating from buildings. Since it takes time to evaluate the potential threat, the first responder is left to choose. People are potentially allowed to continue travel and risk the further spread of biological agents, or potentially the area may be isolated and only spilled coffee cream It can cause great confusion and expense.

US Provisional Patent Application No. 60 / 929,577

  Efforts have been made to develop portable detection units, such as polymerase chain reaction (PCR) units, in order to identify biological agents more quickly and respond to attacks. However, these portable units often can only be used by highly trained professionals, making it difficult to use in the field. Thus, there is a need for a portable detection unit that can be used easily and effectively by field personnel who are not well trained.

  One aspect of the invention relates to a method and apparatus for providing updated assay information to a portable detection unit by a remote server. The remote server can also provide a modified annealing temperature for strain differentiating assays to the portable detection unit.

  Another aspect of the invention relates to a consumable for use in a portable detection unit. The consumable comprises a memory unit that can provide information to the portable detection unit. The information can include what the detection protocol is to be used for, for example, assay parameters or detection parameters. The consumable can also comprise a communication unit, for example a microprocessor. The communication unit can send information from the memory unit to the portable detection unit or the remote server, or receive information from the portable detection unit or the remote server, for example. For example, the communication unit can receive data from a remote server and then communicate this data to the portable detection unit.

  The consumables can be labeled with an identification device, such as a barcode, for use with a portable detection unit. The identification device can provide information to the portable detection unit. For example, the identification device can specify the assay parameters used, including assay temperature parameters, timing, and detection parameters. The identification device can also easily identify the reagent or the amount of the reagent, so that the portable detection unit can perform an appropriate analysis and an appropriate analysis of the results. The identification device can be used instead of or in addition to the memory unit. For example, the consumable can include an identification device to identify the type of detection protocol and the memory unit containing the detection protocol parameters. Any type of barcode can be used, including linear barcodes, matrix barcodes (also known as two-dimensional barcodes), and stack barcodes. The identification device can also include assay parameters including assay temperature parameters, assay timing parameters, and assay detection parameters.

  Another aspect of the invention relates to maintaining cycling data specific to reactions on consumables by a remote server and transmitting cycling data to a portable detection unit.

  Another aspect of the present invention provides global positioning system (GPS) information to the portable detection unit, so that the unit determines its current altitude and is performing a PCR procedure for an unknown substance. The melting temperature used during the process can be adjusted so that it does not boil, for example during the denaturation phase of the PCR procedure. Assay parameters such as temperature, timing, and detection parameters can be selected based on the geographic location of the portable detection system as determined by GPS. For example, a first set of assay parameters can be used in the United States, and a second set of assay parameters can be used in Europe. It may be desirable to select various detection protocols or parameters based on different laws and regulations depending on the geographic region.

  In accordance with one aspect of the present invention, a system for testing an unknown sample is provided, which is a portable detection in which assay parameter information for testing an unknown sample against multiple assays is stored. Includes units. The system also includes a remote server that provides updated assay parameter information to the portable detection unit.

  In accordance with another aspect of the invention, a system for testing an unknown sample is provided, which includes a portable detection unit that stores cycling data specific to reactions on consumables. The system also includes a remote server that provides updated cycling data to the portable detection unit.

  Furthermore, according to another aspect of the invention, a portable detection unit for testing an unknown sample is provided. This unit includes a memory in which assay parameter information for testing an unknown sample against a plurality of assays is stored, the assay parameter information including a minimum melting temperature for each of the plurality of assays. The unit may also include a determination unit configured to determine the current altitude relative to the sea level of the portable detection unit. The unit can further include a melting temperature recalculation unit configured to recalculate the melting temperature for the plurality of assays based on the current altitude of the portable detection unit.

  It is to be understood that both the foregoing summary and the following detailed description are exemplary and explanatory only and are not restrictive of the scope of the claimed invention.

  The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several embodiments of the invention and together with the description serve to explain the principles of the invention.

1 shows a system for updating assay parameter information of a portable detection unit according to a first embodiment of the invention. FIG. FIG. 4 shows a system for updating assay parameter information of a portable detection unit according to another embodiment of the invention. 1 shows a portable detection unit according to at least a first embodiment of the invention. FIG. FIG. 5 is a block diagram illustrating a system for determining an accurate melting temperature based on the current altitude of a portable detection unit according to another embodiment of the present invention. It is a figure which shows the canister containing the consumable which may be utilized in either of embodiment of this invention.

  Reference will now be made in detail to embodiments of the invention, examples of which are illustrated in the accompanying drawings. Efforts have been made to use the same reference numbers throughout the drawings to refer to the same or like parts.

  Unless stated otherwise, “and” can mean “or” and “or” can mean “and”. For example, if a feature is described as having A, B, or C, the feature can have A, B, and C, or any combination of A, B, and C. Similarly, if a feature is described as having A, B, and C, the feature can have only one or two of A, B, or C.

  Unless explicitly stated, “a” and “an” can mean “one or more than one”. For example, if a device is described as having one feature X, the device may have one or more features X.

  FIG. 1 shows a portable detection unit 100 in communication with a remote server 110 according to a first embodiment of the present invention. Any portable detection unit can be used. In some embodiments, the portable detection unit can be designed to perform PCR analysis. Portable detection can also be designed to perform other types of analysis, such as ion mobility spectrometry (IMS), mass spectrometry, or affinity-based analysis. Examples of affinity-based analysis include protein affinity analysis, such as antibody binding analysis or the use of protein sequences. The portable detection unit performs one or more types of analysis. For example, a portable detection device evaluates an analyte based on size, followed by other types of analysis, such as PCR, mass spectrometry, or affinity-based analysis, depending on the type and size of the analyte. be able to. In one embodiment, the portable detection unit first determines the size of the analyte, for example by using mass spectrometry, followed by PCR if the analyte meets the limit criteria.

  In some embodiments, the portable detection unit 100 may correspond to a Bioseq ™ unit (Smiths Detection Inc.), such as a Bioseq Plus ™ unit. Alternatively, the portable detection unit 100 can correspond to an improved Bioseq ™ unit, the improvements being described in detail below. In an improved Bioseq ™ unit or Bioseq Plus ™ unit, the user (or operator) does not need to perform complex functions to analyze the sample; rather, the user collects an unknown sample Select one or more specific assays (for example, in Bioseq2 the memory chip can contain assay details) and are executed by the portable detection unit 100 and then presented on the display of the portable detection unit 100 You just have to wait for the results of those assays to be performed.

  The portable unit can accommodate multiple simultaneous assays. The number of simultaneous assays will depend on the application and the particular instrument. For example, the Bioseq Plus ™ unit supports up to six independent simultaneous assays, a thermocycler heater for temperature stability, a keyboard for the user to enter information, And a built-in battery that can be charged. Assays that can be used with the Bioseq Plus ™ unit include, for example, a) anthrax, b) tularemia, 3) plague, 4) orthopox, 5) lysine, and 6) training consumables. Other assays can be used depending on the desired application. The assay protocol is stored in the memory of the Bioseq Plus ™ unit. Again, the Bioseq ™ unit can be used as a portable detection unit, but other types of portable detection devices can also be used.

  The Bioseq ™ unit can be used as a portable detection unit, but any portable detection unit can be used. The portable detection unit can be designed to perform PCR analysis. Portable detection can also be designed to perform other types of analysis. In some embodiments, the portable detection unit performs one or more types of analysis. For example, a portable detection device can evaluate an analyte based on size, and then evaluate based on either PCR or mass spectrometry or affinity-based analysis depending on the type and size of the analyte.

  In the first embodiment, communication between the portable detection unit 100 and the remote server 110 is performed via a wireless communication link, which provides a link to the remote server 110 via the Internet 120. Alternatively, the link can provide a direct link to the remote server 110. The portable detection unit 100 and the remote server 110 can communicate via satellite or one or more relay devices, such as a workstation. The relay device can be set up at a site that is remote from both the portable detection unit 100 and the remote server 110 sites. For example, the portable detection unit 100 may be used at a potential bioterrorist attack site and communicate with a workstation located at a command site outside a potentially contaminated area, for example, via a wireless communication link. These workstations can then communicate with the remote server 110 to send information to or from the portable detection unit 100.

  The information received by the portable detection unit 100 can be information used to analyze the sample. For example, the remote server 110 can specify the type of assay to be performed. In some embodiments, the remote server 110 can communicate with the portable detection unit 110 to instruct the portable detection unit 100 to perform a specific PCR assay, eg, an anthrax assay. In some embodiments, the portable detection unit 100 can communicate the results of the assay to the portable detection unit 110. Based on this information, the remote server 110 can send instructions to perform additional assays or to modify previous assays in some way. For example, if the result of the first assay is negative, additional assays will be performed. In this way, the remote server 110 can send instructions to perform the assays necessary to identify the sample or to exclude samples that contain a particular drug.

  The remote server 110 can also specify conditions under which the assay can be performed by the portable detection unit 100. Conditions can be, for example, reagent type and amount, reaction to be performed, timing of each step, temperature to be maintained, detection parameters, and the like. In some embodiments, the assay is a PCR assay and the remote server 110 informs the portable detection unit 100 about the reagents used, the number of cycles, the time of each cycle, the temperature during each cycle, the temperature profile, the detection temperature, Alternatively, detection excitation and emission wavelengths are provided.

  By providing information to the portable detection unit 100, the portable detection unit 100 can be operated by very limited trained personnel. In one embodiment, portable detection unit 100 is a Bioseq Plus ™ unit. The remote server 110 can provide information to the Bioseq Plus ™ unit to specify the assay to be run and the conditions to be used to run the assay. In some embodiments, the user need not enter anything other than the sample to be tested into Bioseq ™.

  In the first embodiment, assay parameters are provided to the portable detection unit 100 via a wireless communication link from a remote server 110 (remotely located with respect to the portable detection unit 100), and thus the portable detection unit 100's The user has the latest information downloaded to the portable detection unit 100 in order to analyze gases, liquids and / or solids by the portable detection unit 100. Although not shown in FIG. 1, a memory for storing program parameters for storing assay parameters and performing PCR steps on unknown samples being collected for analysis by portable detection unit 100 Is provided in the portable detection unit 100.

  The remote server 110 is provided with a link to a central facility, eg, a medical research facility, preferably a secure link (eg, using an encryption algorithm and a decryption algorithm), so that updated assay information is remote from the medical research facility. Periodically provided to the server 110, the information can be downloaded to the portable detection unit 100 when needed. The remote server 110 can receive information on a regular basis, for example, once an hour, once a day, or once a week. The remote server 110 may also receive information on demand, for example when the remote server receives information that the portable detection unit has been activated, or when the portable detection unit is about to perform an assay.

  In the first embodiment, when a user switches on his portable detection unit 100, the portable detection unit 100 outputs an “awake” signal, which is a local communication system (eg, cellular). System, satellite system or WI-FI system). The remote server 110 is notified of this arousal by providing a wake-up signal to the remote server 110 wirelessly from the local communication system and / or via the Internet. The remote server 110 then checks its latest assay information with the assay information previously transmitted to the portable detection unit 100 when the portable detection unit 100 was last awakened, and the update of the assay information is The remote server 110 automatically provides the portable detection unit 100 as needed. Alternatively, the updated assay information is such that consumables (eg, canisters with consumables) have been placed in specific bays of the portable detection unit 100 to begin running the assay on the collected sample. Only provided to the portable detection unit 100.

  As an example, assume that the portable detection unit 100 is being used to check a patient's influenza virus in a hospital. An influenza identification assay with parameters for detecting the latest threat virus is stored on the remote server 110 and then along with the accurate annealing temperature for performing one or more lineage identification assays, the portable detection unit 100. Will be downloaded. After the updated information has been downloaded to the portable detection unit 100, to inform the user that the user can begin to test for a positive new influenza virus patient (eg, of the portable detection unit 100). Notification is provided by a message on the display and / or by a beep or both. Such an update of the assay parameters stored in the portable detection unit 100 is performed without changing the chemical nature of the stockpile consumables of the portable detection unit 100. Stock consumables correspond to stored reagents (eg, in a canister) for use by the portable detection unit 100 that performs various assays (eg, consumable A has been collected by running the assay). Used as a reagent to determine if the sample is anthrax, consumable B is used to run the assay to determine if the collected sample is plague).

  In one possible embodiment, the portable detection unit 100 is housed on a tray that houses multiple (eg, three or more) canisters containing consumables for performing a particular assay. Is done. To perform a specific assay that requires a specific consumable, the canister for the specific consumable is placed in a specific bay on the tray to begin performing the specific assay. If the canister containing a particular consumable is empty (eg, indicated by a message on the display of the portable detection unit 100), the user can perform a particular assay that requires that particular consumable as a reagent. To do so, you must remove the empty canister from the bay and insert a new canister with the same consumables.

  In the second embodiment, the consumable contains information to be supplied to the portable detection unit 100. This information may be stored on the consumable using a memory unit, identification device, or other suitable information storage tool. The identification device can be, for example, a bar code or an RF ID. The information can be communicated to portable detection unit 100 or remote server 110, as described in more detail below, or received from portable detection unit 100 or remote server 110 and stored in memory.

  The consumables can include various reagents necessary to perform the assay, or probes used to detect the analyte. For example, the consumable can be a PCR consumable that contains the reagents, primers, and probes used to perform the PCR assay. Consumables can be specific to a particular type of assay. For example, consumables are PCR for use in assays to detect specific biological agents such as anthrax, plague, foot-and-mouth disease, bird flu, swine cholera, Barrett's esophagus, MRSA, HIV, HCV, HPV, or thremia. It can be a consumable. If a memory unit is used, the memory can be attached to the consumable in any manner (eg, on the outer surface of the canister where the consumable is provided). For example, the memory can be embedded in or attached to the consumable using, for example, an adhesive. The memory unit can be provided in the form of an electronic chip. Similarly, an identification device, such as a barcode, can be placed anywhere on the consumable. The only limitation is that the identification device must be readable by the portable detection unit.

  The memory can be any form of memory, such as random access memory, flash memory, or other memory suitable for storing information. The memory can communicate with one or more components, such as a microprocessor. For example, the memory can be part of an electronic chip that includes a microprocessor and apparatus for communicating data stored in the memory to the portable detection unit 100 or the remote server 110. In some embodiments, the memory is provided in the form of a radio frequency identification (RF ID) chip. For ease of reference, the terms “memory” and “chip” are used interchangeably.

  The memory can include information to identify the type of consumable. For example, the memory can identify a consumable as a consumable to be used to identify a particular biological agent, such as a plague, anthrax, smallpox, influenza, or thremia. The memory can also identify the consumable as a whole, for example, by the type of reagents and probes contained within the consumable. Based on this information, the user of portable detection unit 100 can select specific detection parameters. For example, a consumable can identify itself as a PCR consumable for plague detection for the portable detection unit 100, in which case the user can select a particular parameter, such as the number of cycles.

  The memory can also contain information used to perform the assay. This information can include the type of assay to be performed, assay parameters, and detection parameters. For example, the memory can specify reaction steps, amount and type of reagents to be used, and reaction conditions such as time and temperature. Thus, the memory can provide all of the information necessary for the portable detection unit 100 to perform the assay and detect the sample. In some embodiments, the user may have the option to change the parameters provided by the memory. This allows a sophisticated user to optimize settings, modify settings that are incorrectly provided by the memory, or perform maintenance.

  Information can also be stored on the consumable using a barcode. Bar codes can be used to store the same type of information as the memory, as described above. In some embodiments, both barcodes and memory can be used. For example, the bar code can identify the type and amount of consumables, and the memory can include test parameters. Bar codes can also be used to support at least some of the information on the memory.

  In some embodiments, the consumable is a PCR consumable and the information contained in the memory or identification device includes information necessary for the portable detection unit 100 to perform a PCR assay. The memory can specify, for example, the reagents used, the number of thermal cycles, the time of each cycle, the temperature during each cycle, the temperature profile, the detection temperature, or the detection excitation and emission wavelengths. In some embodiments, the information regarding the PRC consumable provides all of the information necessary for the portable detection unit 100 to perform the assay so that the user does not need to provide any information. In other embodiments, the information provides only some of the required parameters and the user provides additional parameters to the portable detection unit. In other embodiments, all or supplemental information is provided by communication between the portable detection device and the remote server.

  Because the consumable can use memory or an identification device to provide all or substantially all of the information necessary to perform the assay to the portable detection unit 100, the consumable allows the portable detection unit to Can be operated by very limited trained personnel. For example, the portable detection unit 100 may be operated by soldiers or emergency medical personnel who have not received formal scientific training. Errors are also minimized. This is because the parameters are provided by the consumable rather than the user who can enter the parameters incorrectly.

  In some embodiments, the consumable with memory can send and receive information from the remote server 110 as described above in connection with the first embodiment, whereby the portable detection unit 100 can We are not involved in this information transfer. In those embodiments, the information provided to the consumables by the remote server 110 is portable from the consumable memory only when the consumables are to be utilized to perform a particular assay with the portable detection unit 100. It is transferred to the detection unit 100 (by the consumable communication unit). Accordingly, the remote server 110 can receive the information provided by the memory or provide information to be stored in the consumable memory. For example, if the assay parameters are optimized after manufacture of the consumable, a wireless communication link can be used to change the parameters stored in the consumable memory to match the optimization parameters. The consumable memory may also be read to determine the type of consumable. Such reading can be performed using an RFID communication protocol. This can be useful, for example, to create a list of consumables stored in a warehouse.

  In some embodiments, the portable detection unit 100 can read information about the consumable identification device and transfer the information to the remote server 110. The remote server 110 can then specify the type of test or test parameter to be performed by the portable detection unit 100.

  In some embodiments, both the consumable and the remote server 110 provide information to the portable detection unit 100. For example, a consumable memory or identification device can provide the consumable and the type of reagent contained, and the remote server 110 can provide assay and detection parameters. As another example, the consumable memory or identification device can provide all information necessary to perform the assay to the portable detection unit, and the remote server 110 verifies that the information is up-to-date. Or update information if necessary.

  The consumable with memory or identification device and the portable detection unit 100 can be designed to communicate automatically, or the user can initiate an exchange of information. For example, after the consumable is mounted on the portable detection unit 100, the portable detection unit 100 can automatically read information from the consumable. The portable detection unit can also ask the user if the user wants to use the information stored in the consumable or other information.

  In one embodiment, the consumable is in the form of a canister and the memory is part of a chip attached to the canister. When the portable detection unit 100 detects the presence of a chip on the canister when the canister is installed in the bay, the portable detection unit 100 thereby performs a specific assay using the consumable. When it is determined that it should be, updated assay parameter data is provided from the remote server 110 to the portable detection unit 100 without requiring input from the user. Thus, all the user has to do is collect the sample, place the consumable in the bay of the portable detection unit 100, and the portable detection unit 100 can automatically detect the chip on the consumable in the bay. And then allowing the consumable and the latest assay parameter information to be used to automatically perform the assay. Once the automatic update is complete, such a display can be made by an audible display and / or a visual display, the user can make an appropriate selection on the portable detection unit 100 (e.g., perform a lysine test button). Or by making an appropriate selection on the touch screen display), it is only necessary to initiate the execution of a specific assay. In another possible embodiment, the results of the assay, the date and time the assay was performed, the location where the assay was performed, and the user input date (e.g. log number) provided to perform the assay are stored on the chip. The

  In one possible implementation of the first embodiment, the consumable chip is an RF ID chip, which detects the presence of a consumable chip in a particular bay in the tray of the portable detection unit 100 and provides information (eg, (Computer software stored in the memory of the RFID chip) is obtained from the chip, and the portable detection unit 100 performs a specific assay using the information obtained from the chip. Such information can include, for example, cycle time, cycle temperature, temperature profile, number of cycles, detection temperature, detection excitation parameters, and emission wavelength. Again, the actual steps of performing a particular assay are not described in detail below because these steps are well known.

  In the third embodiment of the present invention, the remote server 110 holds data specific to reactions on consumables. Updated data is provided to the portable detection unit 100 by the remote server 110 when the portable detection unit 100 is to perform a particular assay. Updated data may also be provided to the consumable memory directly from the remote server 110 or via the portable detection unit 100. As such, product updates are not visible to the user of portable detection unit 100. In addition, if there is a new reaction optimization, it may be identified (eg, by a scientist working at a research hospital) and provided directly to the remote server 110 so that the information is then portable as needed. It is downloaded to the detection unit 100 or the consumable memory. These downloads can be based on the manufacturing data of the portable detection unit 100, the assay and consumable identification information, or the date of manufacture of the consumable. As an example, when the remote server 110 is provided with updated data for a particular PCR procedure (e.g., the annealing temperature used during cycle 2 is an optimization test for a particular PCR procedure). From 93 ° C. to 95 ° C., so that updated information is provided to the remote server 110 via a dedicated communication link between the laboratory and the remote server 110, as determined by the scientist running at The information is provided to the portable detection unit 100 via a wireless communication link. Thus, by using a specific consumable housed in a canister provided with a chip (eg, an RF ID chip), all future PCR procedures performed on the sample under test will be updated cycling. Use data.

  FIG. 2 shows a remote server 110 having a memory 125 for storing the latest data, where the latest data is received by the switch of the portable detection unit 100 (“awake” output by the portable detection unit 100 as described above. ”Signal) or when the data is being updated in memory 125 is provided to portable detection unit 110. As such, when the data is updated in the memory 125 of the remote server 110 after the portable detection unit 110 is switched on, the event is sent from the remote server 110 of the updated data to the portable detection unit 100. Automatically download (portable detection unit 100 receives and stores updated cycling data when it is switched on). Alternatively, the data is provided to the portable detection unit 100 when a canister containing a specific consumable to be used to perform a specific assay is placed in the bay of the portable detection unit 100. The chip on the outer surface of the canister is then detected, thereby causing the portable detection unit 100 to send a signal requesting updated cycling data from the remote server 110. The detection of the canister in the bay can be performed by a low-power antenna provided in the vicinity of the tray. For example, the low power antenna can be located 1 inch from the bay, so that the low power antenna detects only the signal from the RF ID chip provided on the canister in the bay and on the tray A signal from an RF ID chip provided on another unused canister provided further away from the antenna is not detected. The remote server 110 then sends the latest cycling data by wireless signal to the portable detection unit 100, which then uses the latest data when performing the assay using the consumables.

  FIG. 3 shows a portable detection unit 100 having three storage bays 310 and one use bay 305. Although the number of storage bays 310 is based on the number of different consumables (and thus the number of different canisters) required to perform different types of assays by the portable detection unit 100, FIG. Only one storage bay 310 is shown. However, the portable detection unit 100 can have any number of storage bays 310. For example, the portable detection unit can have one, two, three, four, five, six, or more storage bays 310. If a specific assay is performed using a specific consumable, the canister containing the specific consumable is transferred from one of the storage bays 310 to the use bay 305. The RF antenna 315 can detect the RF ID chip provided on the outer surface of the canister provided in the use bay 305, and the assay information stored in the chip is then used, for example, for the thermostat of the portable detection unit 100. Provided to the cycler unit 320. As described above, before the portable detection unit 100 performs a specific assay using a specific consumable, the portable detection unit 100 can notify the remote server 110, which can then In some cases, updated assay parameter (and / or cycling data) information is provided to the portable detection unit 100. When the download is complete, the portable detection unit 100 performs a specific assay on the collected sample using the updated information.

  A fourth embodiment of the present invention will be described below with reference to FIG. In the fourth embodiment, the portable detection unit 400 includes a global positioning system (GPS) receiver, and thus the current position of the portable detection unit 400 can be determined. Methods for determining unit locations based on GPS data are well known in the art and are not discussed herein for the sake of brevity (eg, by using GPS data from at least three different GPS satellites, You can get precise position coordinates anywhere on the surface of the Earth). In the fourth embodiment, the GPS data is utilized by the portable detection unit 400 to modify and / or control assay parameters stored in the portable detection unit 400 or consumable memory.

  More specifically, by way of example, even if a very high melting temperature (eg, 95 ° C.) is used during a PCR procedure performed by the portable detection unit 400, the minimum melting temperature for the assay will sign the consumable. Will be converted. This encoding can be performed by a chip (eg, an RF ID chip) provided on a canister containing consumables, or a bar code or other type of permanent or semi-permanent provided on the outer surface of the canister. It can also be done by indicia, whereby the barcode scan by the portable detection unit 400 is read and stored by the portable detection unit 400 so that the appropriate PCR procedure performs one or more assays. Can be performed to obtain enough collected sample to do.

  More particularly, the PCR procedure includes three steps: a denaturation phase, an annealing phase, and an expansion phase. The denaturation step is a step in which the DNA fragments of the collected sample are heated to a high temperature, thereby reducing the double strands of DNA to single strands and making these single strands accessible to the primers. The annealing step is the step where the reaction mixture is cooled, the primer anneals the complementary region in the DNA template strand, and the duplex is again formed between the primer and the complementary sequence. The extension step is the step where the DNA polymerase synthesizes the complementary strand, whereby the enzyme reads the opposing strand sequence and extends the primer by adding nucleotides in the order in which they can be paired. This three-step PCR process is repeated many times so that temperature cycling causes copying of copies, etc., so that an exponential increase in the number of copies of a particular sequence (ie, the amount of sample to be tested) Increase). Once a large amount of sequence is obtained, the portable detection unit 300 can perform a sufficient amount of sample analysis to determine whether the sample poses a threat.

  Based on the GPS data provided to the portable detection unit 400, the portable detection unit 400 can easily determine its current altitude, thereby correcting the melting temperature to avoid boiling. In a fourth possible implementation, the portable detection unit 400 has an internal memory (eg, read-only memory) that stores altitude data based on a specific GPS location (latitude and longitude in degrees, minutes, and seconds). Or a remote server (not shown, but see FIGS. 1 and 2) based on GPS data wirelessly transmitted from the portable detection unit 400 to the remote server. 400 can provide accurate altitude information. For example, if portable detection unit 400 is at an altitude of 10,000 feet, the temperature at which the liquid is boiled will be lower than if it should be at sea level, but the exact boiling temperature based on altitude is And are not discussed herein for the sake of brevity. Computer program code for calculating the exact boiling temperature based on the temperature is stored in the melting temperature calculation unit 420 of the portable detection unit 400 (see FIG. 4).

  Referring to FIG. 4, the portable detection unit 400 includes a GPS receiver 430 that receives GPS information from GPS satellites and that information is provided to the altitude determination unit 440. The altitude determination unit 440 determines the current altitude of the portable detection unit 400 relative to the sea level. The current altitude is provided to the assay analyzer 410, which sends that information along with information about the particular assay to the melting temperature calculation unit 420, resulting in a modified based on the current altitude for the assay. The melting temperature can be determined. Based on the modified melting temperature provided to the assay analyzer 410 by the melting temperature calculation unit 420, the assay analyzer can perform an appropriate assay (more specifically, the assay analyzer can perform DNA analysis of the sample). By heating the fragment at a temperature that is high enough but not high enough to boil, a suitable denaturation step of the PCR procedure can be performed).

  Based on well-known calculations that relate altitude and boiling temperature, the melting temperature can be easily determined by portable detection unit 400 regardless of its current altitude (eg, mountain or underwater use). If it is determined that the minimum melting temperature is above the calculated boiling point of water at the GPS determined location of the portable detection unit 400, the portable detection unit 400 issues a warning message on the display (which may be an alarm) and the portable detection unit 400 Prevent the assay from being performed. Otherwise, the assay can be performed on the portable detection unit 400, and the heating temperature of the denaturation phase of the PCR procedure is lowered to avoid boiling if necessary. Thus, the third embodiment provides an added safety feature that is not currently available for conventional portable detection units.

  GPS information, such as geometric location, can also be used to determine assay parameters, such as temperature, timing, and detection protocol, either automatically or at the user's instruction. For example, a first set of assay parameters can be used in a first country and a second set of assay parameters can be used in another country. It may be desirable to select different detection protocols or parameters based on different laws and regulations depending on the geographic region. As an example, assay protocol A can be used when within a defined geographic region, while assay protocol B can be used within all other regions. Selecting assay methods and parameters based on geographic region can be useful for a variety of reasons. For example, different methods or parameters may be required to comply with laws and regulations in different geographic regions. Selecting different test methods and parameters based on geographic region can also be useful to avoid infringing on intellectual property rights that exist only within a particular jurisdiction. As another example, test methods and parameters can be adjusted based on the prevalence of different analytes in different regions. Portable detection unit 400 may be configured to select a test protocol or parameter based on data provided by GPS. Alternatively, the GPS data may be sent to a remote server that in turn provides a test protocol or parameter to the portable detection unit 100. In another embodiment, the test method or parameter is selected based on both GPS data and information provided in the form of memory or barcode by the consumable as described above.

  In some embodiments, the information provided by the consumable can be used to select a test method, such as a nucleic acid identification method, a protein identification method, or a combination thereof. Examples of nucleic acid identification methods include PCR, that is, Linear After the Exponential PCR (LATE-PCR), and reverse transcription PCR (RT-PCR). Protein identification methods include, for example, affinity binding based methods such as antibody-antigen assays.

  In a fifth embodiment, the portable detection unit performs one or more assays based on the results of the first assay. The detection unit evaluates the results of the first assay, directly or via communication with the remote server, determines whether to perform the second assay, and if the second assay is performed Can determine what type of assay is performed. For example, a portable detection unit can perform an antibody assay that sifts multiple targets, and subsequent assays, such as PCR, are performed depending on which one target is detected. Other assays may be determined depending on subsequent results. As another example, the portable detection unit can determine the size or amount of the analyte in the sample. Subsequent tests can be performed based on the size, quantity or type of analyte. Parameters can also be selected based on the results of previous tests. For example, after an inconclusive assay, the parameters can be adjusted to obtain the final result.

  The decision on whether to perform the second test or which second test to perform can be made by the portable detection unit. This determination may be made by the portable detection unit based on, for example, software residing in the unit. The portable detection unit can also transfer data from the first test, alone or in combination with GPS data, to the remote server, as described above, and the remote server will then perform any test, if any. You can specify what to do. Thus, it is the remote server that determines which subsequent analysis, if any, to perform. The portable detection unit can also use the results of the first test in connection with the information stored on the consumable to determine which subsequent analysis, if any, to perform. For example, a subsequent analysis may be selected (a) based on the first analysis that failed, using (b) a consumable for detecting a set of predefined analytes. Subsequent analysis may be performed using consumables for detecting the second set of predefined analytes.

  Although the fourth embodiment has been described primarily as it relates to PCR analysis, the fourth embodiment can be used in any assay. For example, the fourth embodiment can be used in mass spectrometry, IMS, or binding affinity based techniques such as antibody binding. Altitude differences can affect tests that rely on any parameter that depends on altitude, such as atmospheric pressure or melting point and boiling point. Further, different geographic regions may require different methods or parameters because, as described above, are highly fully dependent.

  FIG. 5 shows a canister 500 provided with a chip 510 on the outer surface according to first to fifth embodiments of the present invention. In another possible embodiment, two chips are provided at opposite positions on the canister 500, so that the antenna 315 (see FIG. 3) is related to the placement of the canister 500 in the use tray 305 of the portable detection unit. In addition, the RF ID chip can be detected. Tip 510 is preferably fixedly attached to the outer surface of canister 500, for example, by screwing it in place, welding it in place, or gluing it in place.

  The embodiments described above are described herein for purposes of illustration. However, this description should not be regarded as a limitation on the scope of the invention. Various modifications, adaptations, and alternatives may occur to those skilled in the art without departing from the claimed concept of the invention. For example, sample preparation parameters as well as PCR parameters can be provided from a remote server to the portable detection unit. For example, a consumable can incubate a sample in a particular buffer for 5 minutes, then perform some operations, and then incubate the sample for an additional 5 minutes. Based on that, the remote sensor provides optimal parameters for proceeding with the assay to be performed by the portable detection unit. Moreover, regarding the third embodiment, it is possible to adjust the culture time of consumables so as to occupy a lower use temperature by using a temperature sensor (when the culture time is related to the use temperature). Furthermore, changing the cycling parameters can affect the analytical parameters to be used to perform the assay, and vice versa, so that the appropriate cycling parameters and analysis Parameters are consequently provided from the remote sensor to the portable detection unit. The spirit and scope of the invention is indicated by the following claims.

Claims (41)

A system for testing an unknown sample,
A portable detection unit storing assay parameter information for testing the unknown sample against a plurality of assays;
A remote server that provides updated assay parameter information to the portable detection unit. The portable detection unit comprises:
The system of claim 1, comprising a wireless transceiver for wireless communication with the remote server. The portable detection unit comprises:
Means for notifying the remote server when the portable detection unit is switched on;
The remote server is
Means for determining whether the current assay parameter information stored is different from the assay parameter information stored in the portable detection unit and, if different, outputting the current assay parameter information to the portable detection unit The system of claim 2, comprising: A system for testing an unknown sample,
A portable detection unit that stores data specific to reactions on consumables;
A remote server providing updated data to the portable detection unit. The portable detection unit comprises:
The system of claim 4, comprising a wireless transceiver for wireless communication with the remote server. The portable detection unit comprises:
Means for notifying the remote server each time the portable detection unit is switched on;
The remote server is
Means for determining whether stored current data differs from cycling data stored in the portable detection unit and, if different, outputting the current cycling data to the portable detection unit. 5. The system according to 5. A portable detection unit for testing unknown samples,
A memory storing assay parameter information including a minimum melting temperature for each of the plurality of assays for testing the unknown sample against the plurality of assays;
An altitude determination unit configured to determine a current altitude relative to the sea level of the portable detection unit;
A portable detection unit comprising a melting temperature recalculation unit configured to recalculate melting temperatures for the plurality of assays based on the current altitude of the portable detection unit. Configured to prevent performing the specific assay using a portable detection unit when the recalculated melting temperature is determined to be higher than the minimum melting temperature for the specific assay The portable detection unit according to claim 7, further comprising a prevention unit. 8. The portable detection unit of claim 7, further comprising a prevention unit configured to prevent a specific assay from being performed using the portable detection unit based on predetermined criteria.   9. The portable of claim 8, wherein a prevention unit outputs at least one of an audible warning or a text warning on the display of the portable detection unit to inform the user to prevent the particular assay from being performed. Detection unit. A method for testing an unknown sample,
Storing assay parameter information for testing the unknown sample against a plurality of assays in a portable detection unit;
Providing updated assay parameter information to the portable detection unit by a remote server. Said providing step comprises:
12. The method of claim 11, comprising wirelessly communicating the updated assay parameter information from the remote server to the portable detection unit. Notifying the remote server by the portable detection unit whether the portable detection unit has been switched on;
The remote server determines whether the current assay parameter information stored is different from the assay parameter information stored in the portable detection unit, and if so, sends the current assay parameter information to the portable detection unit. 13. The method of claim 12, further comprising the step of outputting. A method for testing an unknown sample,
Storing cycling data specific to reactions on consumables in a portable detection unit;
Providing updated cycling data to the portable detection unit by a remote server. Said providing step comprises:
15. The method of claim 14, comprising wirelessly communicating the updated assay parameter information from the remote server to the portable detection unit. The portable detection unit comprises:
Notifying the remote server by the portable detection unit whether the portable detection unit has been switched on;
Determining whether the current cycling data stored by the remote server is different from the cycling data stored in the portable detection unit and, if different, outputting the current cycling data to the portable detection unit. 16. The method of claim 15, further comprising: A method for testing an unknown sample with a portable detection unit,
Storing in a memory assay parameter information including a minimum melting temperature for each of the plurality of assays for testing the unknown sample against a plurality of assays;
Determining a current altitude relative to the sea level of the portable detection unit;
Recalculating the melting temperature for the plurality of assays based on the current altitude of the portable detection unit determined by the determining step.   Further comprising preventing the portable assay unit from performing the particular assay when the recalculated melting temperature is determined to be higher than the minimum melting temperature for the particular assay. The method of claim 17.   19. The prevention step of claim 18, comprising outputting at least one of an audible alert or a text alert on the display of the portable detection unit to inform a user to prevent the particular assay from being performed. the method of.   A consumable for use in a portable detection unit comprising a memory or barcode, wherein the memory or barcode contains information for performing an assay.   The consumable according to claim 20, wherein the consumable is a PCR consumable.   21. A consumable according to claim 20, wherein the information for performing an assay includes all of the information required by the portable detection unit to perform the assay.   The consumable according to claim 20, wherein the memory is an RF ID chip.   The consumable according to claim 21, wherein the memory identifies the reagents used and the number of cycles, the time of each cycle, the temperature during each cycle, the temperature profile, the detection temperature, and the detection excitation and emission wavelengths. A communication unit configured to receive information from a remote server;
The consumable according to claim 20, further comprising a transfer unit configured to transfer the information to the memory by the communication unit.   The consumable according to claim 20, wherein the consumable comprises both a memory and a barcode. A system for testing an unknown sample,
A portable detection unit for testing unknown samples using at least one assay;
A consumable having information for performing the assay,
A system in which the portable detection unit can read the information stored on the consumable.   28. The system of claim 27, wherein the information is stored on the consumable using a memory or barcode.   28. The system of claim 27, wherein the portable detection unit is capable of performing at least two assays.   30. The system of claim 29, wherein one of the assays is PCR. A system for testing an unknown sample,
A portable detection unit capable of performing at least two assays for testing a sample, wherein the at least two assays can be of the same assay type or different assay types;
A system comprising software or firmware for controlling the detection unit.   32. The system of claim 31, wherein the assay comprises PCR.   35. The system of claim 32, wherein the assay comprises a binding affinity based assay.   34. The system of claim 33, wherein the binding affinity based assay is an antibody binding assay.   32. The system of claim 31, wherein the assay comprises a first assay and a second assay, the first assay comprises a binding affinity based assay, and the second assay comprises a PCR assay.   32. The system of claim 31, wherein the assays are of the same type.   32. The system of claim 31, wherein the software or firmware resides on the portable detection unit.   32. The system of claim 31, wherein the software or firmware resides on a remote server that communicates with the portable detection unit.   32. The system of claim 31, wherein the firmware or software includes assay parameters.   32. The system of claim 31, wherein results from a first assay are used to determine an assay type for a second assay, wherein the second assay type is determined by the firmware or software.   32. The system of claim 31, wherein results from a first assay are used to determine assay parameters for a second assay, wherein the second assay parameters are determined by the firmware or software.